SUPPLY CHAIN ARTICLES

  • Can America's Retreat On mRNA Be Europe's Opportunity?

    With HHS winding down mRNA vaccine development under BARDA, could Europe seize the opportunity to lead in mRNA innovation? Exploring the policy shift's implications.

  • Therapeutic Oligonucleotides: Regulations & Quality Standards

    Oligonucleotides have surfaced in the past few years as promising therapeutic agents to treat diseases such as neurodegenerative disorders, respiratory disorders, cancer, and diabetic retinopathy. This article recaps a recent USP workshop where participants from regulatory agencies, industry, and academia gathered to discuss best practices and perspectives.

  • Picasso, Pick-Up Lines, & Personalized Medicine: mRNA's Path Forward

    Overall, my presentation on what the mRNA industry can learn from the artist Picasso singled out a few specific areas from which I felt our industry could garner greater inspiration and operational prowess. But given how “collaborative” many of these sources of inspiration are, I’ve introduced each of my takeaways with a surprisingly relevant (albeit bad) art-themed pick-up line. After all, if there’s one sector that knows it takes more than one to “tango,” it’s the mRNA industry.

  • "Mirror, Mirror…": Reflections On Reducing mRNA Production COGS

    Here, I outline three overarching words of wisdom I gleaned from Life Edit Therapeutics’ April Sena; Tune Therapeutics’ Tyler Goodwin; and University of Sheffield’s Adi on how the mRNA/RNA industry can better control production costs — particularly as it relates to raw material sourcing and usage.  

  • mRNA Vaccines: Key Considerations For Development & Manufacturing

    As we wind down National Immunization Awareness Month, this article looks at the complexities around developing and manufacturing mRNA vaccines and how you should address those complexities. Topics include delivery, process validation, long-term effectiveness, GMP, regulatory approval, and more. 

  • ARW's ATMP Manufacturing Must-Reads (2024 NEW YEAR'S RESOLUTIONS EDITION!)

    Day-in and day-out, I write, read, listen to, and watch as much content as I can about CGT and RNA therapy manufacturing, in particular, and/or other ATMP industry-related topics that you should at least be aware of in the manufacturing facility. Once a month, I compile the articles and industry updates I think are most worthy of your time into an unconventional newsletter format (below) and send them out via email.

SUPPLY CHAIN VIDEOS

In this Advancing RNA Live segment, several speakers raise concerns about the industry's ability to accurately measure impurities, particularly dsRNA, arguing that current analytics are insufficient, especially for high-dose therapeutics.

Explore two functional areas that Advancing RNA panelists consider most essential to telling an RNA product’s “story” thoroughly to regulators.

Here, Advancing RNA Live speakers Khaled Yamout, Sanofi’s Francoise Ribes, and Camp4’s Satya Kuchimanchi share which supply chain advancements they would like to see in the near future, as well as how they anticipate these changes & evolutions could impact each modality’s growth.

Camp4’s Satya Kuchimanchi highlights where he has seen the most growth in the oligo supply chain over the past few years, as well as which industry trends have been driving these shifts.

ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS